From Intent to Execution: How Biomedical Concepts Quietly Rewired the Safety Data Pipeline

About this session

Part of Session 7, Track C: Special Topics (Chair: Donna Sattler, Eli Lilly).

A safety intent defined in protocols is silently reinterpreted at each downstream handoff, eroding consistency by submission time. This paper describes an enterprise safety standards initiative that addressed this challenge by anchoring core safety objectives to CDISC Biomedical Concepts (BCs), enabling meaning to travel intact from protocol through SDTM.
Enterprise-level safety endpoints, linked to standard study activities and BCs, drove eCRF design and SDTM specification without study-specific reinterpretation. BC identifiers embedded across artifacts enabled automated semantic validation, surfacing misalignments before first patient. The initiative progressed through three BC maturity levels, consistent definition, semantic reuse, and executable infrastructure with cultural adoption proving the most significant barrier.
This pattern establishes a replicable model for Digital Data Flow, where safety intent becomes machine-readable, reconciliation moves upstream, and consistency is achieved by design rather than manual effort.

Speakers

• CS

  Chithra Subramaniam

  Bristol Myers Squibb

  Speaker

• RG

  Rohini Goyal

  Bristol Myers Squibb

  Speaker